Psychiatric Problems in Children With Acute Lymphoblastic Leukemia and Their Caregivers

NCT06723496 | Active Not Recruiting DMC

• 1 other identifier: psych-oncology
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Cancer in childhood represents a significant health challenge, with approximately 400,000 children and adolescents aged 0-19 years diagnosed annually. The oncological landscape of pediatric populations is characterized by diverse malignancies, with leukemias, brain cancers, lymphomas, and solid tumors such as neuroblastoma and Wilms tumors constituting the predominant diagnostic categories. Among these, acute lymphoblastic leukemia (ALL) emerges as the most prevalent childhood malignancy. Historically, a cancer diagnosis portended an almost invariably fatal outcome. However, contemporary medical interventions have dramatically transformed this narrative. Since 1980, mortality rates across pediatric cancer types have declined by more than 50%, representing a remarkable advancement in clinical oncology. Notably, ALL demonstrates an exceptionally optimistic prognosis, with over 90% of patients achieving complete remission. Despite these encouraging survival statistics, the cancer experience extends beyond physiological parameters. Children diagnosed with leukemia and their familial support systems frequently encounter complex psychological challenges. These manifestations encompass a spectrum of emotional responses, including anxiety, shock, denial, depression, and adaptive difficulties. Critically, these psychological sequelae are not confined to the diagnostic and treatment phases but often persist even after disease remission The multidimensional nature of the cancer experience prompted the emergence of a specialized subdiscipline in 1992. Termed "psycho-oncology" in the United States and "psychosocial oncology" predominantly in European contexts, this field addresses two fundamental psychological dimensions: Emotional and psychosocial responses of patients, families, and caregivers throughout the disease trajectory Psychological, behavioral, and social factors potentially influencing cancer morbidity and mortality. Consequently, contemporary pediatric oncological care adopts a holistic paradigm. The therapeutic objective transcends mere physical restoration, aspiring to ensure the comprehensive social and emotional well-being of both the child and the familial ecosystem.

Conditions

Acute Lymphoblastic Leukemia ALL

Keywords

psychiatry; children; caregivers; Acute Lymphoblastic Leukemia

Outcome Measures

Primary Outcomes (1)

• Evaluation of psychiatric comorbidity in children with ALL and their caregivers at different stages of illness at South Egypt cancer institute

  through study completion, an average of 1 year

Study Arms (2)

cases group

children with ALL

Behavioral: Child Behavioral Checklist (CBCL):is a checklist parents complete to detect emotional and behavioral problems in children and adolescent, it consists of 113 questions for both groups.; Behavioral: parent report on child's responses to stress (PCT):is a questionnaire which is used to obtain mothers' and fathers' reports of their children's coping with cancer; Behavioral: Symptom Checklist -90- Revised (SCL-90-R) for parents; Behavioral: posttraumatic stress disorders by posttraumatic check list -5 (PCL-5) for parents

healthy control group

Behavioral: Child Behavioral Checklist (CBCL):is a checklist parents complete to detect emotional and behavioral problems in children and adolescent, it consists of 113 questions for both groups.; Behavioral: Symptom Checklist -90- Revised (SCL-90-R) for parents

Interventions

Child Behavioral Checklist (CBCL):is a checklist parents complete to detect emotional and behavioral problems in children and adolescent, it consists of 113 questions for both groups. BEHAVIORAL

is a checklist parents complete to detect emotional and behavioral problems in children and adolescent, it consists of 113 questions.

cases group; healthy control group

parent report on child's responses to stress (PCT):is a questionnaire which is used to obtain mothers' and fathers' reports of their children's coping with cancer BEHAVIORAL

It includes a list of 12 cancer -related stressors (e.g., missing school, frequent hospital or clinic visits, changes in personal appearance), and 57 items reflecting voluntary (coping) and involuntary (automatic) stress responses of children /adolescents in response to cancer-related stressors

cases group

Symptom Checklist -90- Revised (SCL-90-R) for parents BEHAVIORAL

It is a method to evaluate psychological problems and identify symptoms, it includes 90 symptoms and evaluate nine symptomatic dimensions

cases group; healthy control group

posttraumatic stress disorders by posttraumatic check list -5 (PCL-5) for parents BEHAVIORAL

It is a 20 -item measure that assess the 20 DSM-5 symptoms of PTSD.

cases group

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The investigators will recruit two groups; first group will be new cases with ALL with their caregivers attending outpatient clinic or admitted inpatient oncological ward and the second group will be healthy control children with their caregivers. Regarding cases group, every patient will be followed for 6 months with the assessment at diagnosis, post induction phase, post consolidation phase and after 3months from the beginning of the maintenance phase.

You may qualify if:

• Newly diagnosed with ALL
• Aged 6 to 18 years old.

You may not qualify if:

• Children with malignancies other than ALL.
• Age \<6 years old and \>18 years old.
• Children with chronic illness e.g., diabetes mellitus, inflammatory bowel disease, congenital heart disease, cerebral palsy, etc.
• Children with history of psychiatric illness or intellectual disability.
• the caregivers:
• The caregivers who are in charge of the case children during treatment.
• The caregivers with history of psychiatric illness.
• B) Control groups:
• the control children:
• Children with matched age and gender to case group.
• Children with history of having malignancy or current malignancy.
• Children with history of medical, chronic illness or psychiatric disorders.
• the control caregivers:
• Caregivers with matched age and gender to the caregivers' case group.
• Caregivers with history of psychiatric illness.

Sponsors & Collaborators

• Assiut University: lead
• South Egypt Cancer Institute: collaborator

Study Sites (1)

Faculty of Medicine,Assiut university,Assiut,Egypt

Asyut, Egypt

Location

Related Publications (2)

• Spinetta JJ, Jankovic M, Masera G, Ablin AR, Barr RD, Ben Arush MW, D'Angio GJ, Van Dongen-Melman J, Eden T, Epelman C, Martins AG, Greenberg ML, Kosmidis HV, Oppenheim D, Zeltzer PM. Optimal care for the child with cancer: A summary statement from the SIOP Working Committee on Psychosocial Issues in Pediatric Oncology. Pediatr Blood Cancer. 2009 Jul;52(7):904-7. doi: 10.1002/pbc.21863.

  PMID: 19142992 BACKGROUND

• Holland JC. Psycho-oncology: Overview, obstacles and opportunities. Psychooncology. 2018 May;27(5):1364-1376. doi: 10.1002/pon.4692.

  PMID: 29749682 BACKGROUND

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of neurology and psychiatry department

Study Record Dates

• First Submitted: November 29, 2024
• First Posted: December 9, 2024
• Study Start: June 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: December 9, 2024

Record last verified: 2024-12

Locations

EG (1)